To Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients

March 21, 2024 updated by: NVP Healthcare

A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients

The purpose of this study is to evaluate the efficacy and safety NVP-2203 in patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial to evaluate efficacy and safety of NVP-2203 in patients

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥ 19 years of age
  • Primary hypercholesterolemia
  • Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

  • The subject not meet the specified LDL-C level
  • Patients who were diagnosed with a malignant tumor within five years before Visit
  • Inadequate subject for the clinical trial by the investigator's decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVP-2203
NVP-2203 Plus other Placebo for up to 8 weeks, oral dose
Drug: NVP-2203
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R1 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R2 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R3 Placebo
Take it once daily for 8 weeks orally.
Active Comparator: NVP-2203-R1
NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose
Drug: NVP-2203-R2 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R1
Take it once daily for 8 weeks orally.
Drug: NVP-2203 Placebo
Take it once daily for 8 weeks orally.
Active Comparator: NVP-2203-R2
NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose
Drug: NVP-2203-R1 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R3 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R2
Take it once daily for 8 weeks orally.
Active Comparator: NVP-2203-R3
NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose
Drug: NVP-2203-R1 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R2 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203 Placebo
Take it once daily for 8 weeks orally.
Drug: NVP-2203-R3
Take it once daily for 8 weeks orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% change in LDL-C level from baseline
Time Frame: Week 8
change in LDL-C level
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% change in lipid panel from baseline
Time Frame: Week 4, 8
change in lipid panel
Week 4, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: SH Lee, MD, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVP-2203_P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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